Device recall
Z-2556-2018: BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is…
FDA device recall · Class II · CryoLife, Inc.
Key facts
| Recall number (Z-number) | Z-2556-2018 |
|---|---|
| Recall event | 80276 |
| Product | BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries). |
| Product code | MUQ |
| Recalling firm | CryoLife, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2019 |
| PMA numbers | P010003 |
| FEI number | 3001451326 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database